Loves Company: Combatting Emotional Disturbance in the Digital Age

April 8, 2022 updated by: Anna Van Meter, Northwell Health
The goal of this study is to determine whether a community-based website that is intended to provide support for adolescents experiencing psychological distress can improve members' mental health outcomes. The investigators want to understand if a digital platform can help young people who are suffering and may be unlikely to access more traditional forms of mental health services.

Study Overview

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Glen Oaks, New York, United States, 10011
        • Northwell Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 14-17
  • Access to internet-connected device
  • Residing in the United States

Exclusion Criteria:

*Inability to assent due to intellectual disability or lack of English language skills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources.
Participants randomized to the intervention condition will be able to communicate with one another and offer social media-based forms of support (e.g., post music, photos, etc).
educational materials related to mental health
links to online mental health resources
Active Comparator: Control
This condition will include access to a website that includes psychoeducation and access to resources.
educational materials related to mental health
links to online mental health resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescent Suicidal Ideation Measure score
Time Frame: 6 months
frequency of suicidal thoughts and behaviors
6 months
Perceived burdensomeness and hopelessness scale score
Time Frame: 6 months
lower burdensomeness and hopelessness in treatment group (lower score better)
6 months
General Behavior Inventory 10D (GBI 10D)
Time Frame: 6 months
symptoms of depression lower in treatment group (lower score)
6 months
Life Satisfaction
Time Frame: 6 months
level of satisfaction with quality of life
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescent Suicidal Ideation Measure score
Time Frame: 12 months
frequency of suicidal thoughts and behaviors
12 months
Perceived burdensomeness and hopelessness scale score
Time Frame: 12 months
lower burdensomeness and hopelessness in treatment group (lower score better)
12 months
General Behavior Inventory 10D (GBI 10D)
Time Frame: 12 months
symptoms of depression lower in treatment group (lower score)
12 months
Life Satisfaction
Time Frame: 12 months
level of satisfaction with quality of life
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
site engagement
Time Frame: 6 months
time spent on site
6 months
General Behavior Inventory 10D (GBI 10D)
Time Frame: weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
changes in depressive symptoms
weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Perceived burdensomeness and hopelessness scale score
Time Frame: weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
change in burdensomeness and hopelessness
weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0062-ZHH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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